Compact prosthetic heart valve device

ABSTRACT

The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

FIELD

The present technology is generally related to prosthetic heart valvedevices, and in particular is directed to prosthetic heart valve devicesfor percutaneous repair and/or replacement of native mitral valves.

BACKGROUND

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atrium and right ventricle which supplies thepulmonary circulation, and the left atrium and left ventricle whichsupplies oxygenated blood received from the lungs into systemiccirculation. To ensure that blood flows in one direction through theheart, atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atrium and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The valve leaflets move apart from each other to open andallow blood to flow downstream of the valve, and coapt to close andprevent backflow or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber from occurring at the proper flow rate and may cause the heartto work harder to pump the blood through the diseased valve. Valvularinsufficiency or regurgitation occurs when the valve does not closecompletely, allowing blood to flow backwards, thereby causing the heartto be less efficient. A diseased or damaged valve, which can becongenital, age-related, drug-induced, or in some instances, caused byinfection, can result in an enlarged, thickened heart that loseselasticity and efficiency. Some symptoms of heart valve diseases caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Symptoms can often be severeenough to be debilitating and/or life threatening.

Heart valve prostheses have been developed for repair and replacement ofdiseased and/or damaged heart valves. Such heart valve prostheses can bepercutaneously delivered and deployed at the site of the diseased heartvalve through catheter-based delivery systems. Such heart valveprostheses can be delivered while in a radially compressed configurationso that the valve prosthesis can be advanced through the patient'svasculature. Once positioned at the treatment site, the valve prosthesiscan be expanded to engage tissue at the diseased heart valve region to,for instance, hold the valve prosthesis in position.

While these valve prostheses offer minimally invasive methods for heartvalve repair and/or replacement, challenges remain to providing heartvalve prostheses for patients with smaller native heart valves than thegeneral population, for example, due to either having a smaller adultstature than the general population, or to being a child or adolescent.In an adult patient population that may benefit from a mitral valveprosthesis for treating mitral regurgitation, for instance, as many as7% may be screened out due to having native mitral valves with annulusperimeters of between 89 mm to 101 mm that are currently considered toosmall to accept known mitral valve prostheses, which are sized forimplantation within native mitral valves having annulus perimeters ofbetween 101 mm to 119 mm. Such native mitral valves having smallerperimeter annuli tend to be more elliptical in shape, than native mitralvalves having larger perimeter annuli, resulting in currently knownmitral valve prostheses also being unsuitable for implantation withinthe smaller perimeter annuli due to those prostheses being substantiallyoversized in the anterior to posterior direction.

Accordingly, there is a need for a mitral valve prosthesis that may bepercutaneously delivered and deployed at the site of a diseased mitralvalve in a patient with a native mitral valve that is too small toaccept known mitral valve prosthesis.

SUMMARY

The devices and methods of this disclosure generally relate to a heartvalve prosthesis that is configured to be implanted within a nativeheart valve having a smaller perimeter annuli with a generallyelliptical shape.

In one aspect, the present disclosure provides a heart valve prosthesisthat includes a valve support with upstream and downstream segmentsrelative to blood flow through a native heart valve of a human heart.The upstream segment of the valve support is configured to support aprosthetic valve component and defines an inflow end of the valvesupport having a first outer diameter. The downstream segment of thevalve support defines an outflow end of the valve support having asecond outer diameter that is greater than the first outer diameter. Theheart valve prosthesis further includes an anchor element that surroundsthe valve support. A plurality of connectors form a downstream portionof the anchor element, the plurality of connectors being angled inwardtoward the valve support to be attached to the outflow end of the valvesupport. The anchor element is spaced from the upstream segment of thevalve support to mechanically isolate the upstream segment of the valvesupport from the anchor element.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with afirst outer diameter of an upstream segment of a valve support that isconstant from a first end of the upstream segment, which defines aninflow end of the valve support, to a second end of the upstreamsegment.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with adownstream end of an upstream segment of a valve support that isadjacent a upstream end of a downstream segment of the valve support,such that the upstream end of the downstream segment has a first outerdiameter and a longitudinally opposite downstream end of the downstreamsegment, which defines an outflow end of the valve support, has a secondouter diameter that is greater than the first outer diameter.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with adownstream segment of a valve support that is flared outwardly from afirst end to a second end thereof, with the first end of the downstreamsegment having a first outer diameter and the second end of thedownstream segment, which defines an outflow end of the valve support,having a second outer diameter that is greater than the first outerdiameter.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with anupstream segment of a valve support that tapers from a first end of theupstream segment having a first outer diameter, which defines an inflowend of the valve support, to a second end of the upstream segment havinga second outer diameter that is smaller than the first outer diameter.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with anupstream segment of a valve support tapered inwardly from upstream todownstream ends thereof such that the downstream end of the upstreamsegment of a valve support, with a first outer diameter, is adjacent toan upstream end of a downstream segment of the valve support with thefirst outer diameter. The downstream segment is flared outwardly fromthe upstream end to a downstream end thereof, with the downstream end ofthe downstream segment, which defines an outflow end of the valvesupport, having a second outer diameter that is larger than the firstouter diameter.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with atissue fixation ring that forms an upstream portion of an anchorelement, the tissue fixation ring being configured to engage hearttissue at or below a native annulus of the native heart valve.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with ananchor element having a tissue fixation ring that is radially spacedfrom an upstream segment of a valve support a distance S in anundeployed state. The tissue fixation ring being configured to be atleast partially deformable into a non-circular shape to adapt to a shapeof an implantation site in a deployed state, such that the tissuefixation ring does not make contact with the upstream segment of thevalve support, and thereby mechanically isolates the upstream segment ofthe valve support from the anchor element when implanted in vivo.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aplurality of connectors of an anchor element that are angled inward froma tissue fixation ring of the anchor element.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aplurality of connectors of an anchor element that are angled inward froma tissue fixation ring of the anchor element, the plurality ofconnectors being configured to flex upward, after implantation, toaccommodate any radial expansion of the tissue fixation ring caused byan increase in size of an implantation site, such as a native annulus,that may occur after deployment.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with ananchor element having a tissue fixation ring that includes one or morecleats extending outward from the tissue fixation ring to engage hearttissue upon implantation.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aprosthetic valve component disposed within an upstream segment of avalve support such that valve leaflets of the prosthetic valve componentopen into a downstream segment of the valve support during diastole.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aprosthetic valve component disposed within an upstream segment of avalve support such that valve leaflets of the prosthetic valve componentachieve an open state having an effective orifice area greater thanabout 1.6 cm² during diastole.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aframe having a valve support that is formed of a stent-like structurehaving one of honeycomb-shaped and closed diamond-shaped cells.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with aframe having an anchor element that is formed of a stent-like structurehaving diamond-shaped cells.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with anoutflow end of a valve support being attached, by a plurality of rivets,to a plurality of connectors of an anchor element.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with ananchor element provided with a plurality of connectors, with each of theconnectors having an inwardly curved substantially V-shape.

In another aspect, which may be combined with any of the other aspectsnoted herein, the disclosure provides a heart valve prosthesis with afirst outer diameter and a second outer diameter. In an embodiment, thefirst outer diameter at an outflow end of the heart valve prosthesis isabout 30 mm and the second outer diameter at an upstream end of ananchor element is about 36 mm, such that the heart valve prosthesis issized for implantation within a patient having a smaller native annulus.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments thereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 depicts a schematic sectional illustration of a heart havingnative valve structures.

FIG. 2 depicts a schematic sectional illustration of a left ventricle ofa heart showing anatomical structures and a native mitral valve.

FIG. 2A depicts a schematic illustration of a native mitral valve of aheart showing normal closure of native mitral valve leaflets.

FIG. 3 depicts a perspective view of a heart valve prosthesis inaccordance with an aspect of the disclosure.

FIG. 3A depicts a sectional view of the heart valve prosthesis of FIG.3, taken along line A-A thereof.

FIG. 3B depicts a perspective view of a valve support of the heart valveprosthesis of FIG. 3 with a prosthetic valve component secured thereinin accordance with an aspect of the disclosure.

FIG. 3C depicts an atrial view of the heart valve prosthesis shown inFIG. 3 in accordance with an aspect of the disclosure.

FIG. 3D depicts a ventricular view of the heart valve prosthesis shownin FIG. 3 in accordance with an aspect of the disclosure.

FIG. 4 depicts a side view of a frame of a heart valve prosthesis in anundeployed state in accordance with an aspect of the disclosure.

FIG. 4A depicts a side view of the frame of FIG. 4 in a deployed statein accordance with an aspect of the disclosure.

FIG. 4B depicts a sectional view of a portion of the frame of FIG. 4A inthe deployed state in accordance with an aspect of the disclosure.

FIG. 5 depicts a side view of a frame of a heart valve prosthesis inaccordance with an aspect of the disclosure.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to a nativevessel, native valve, or a device to be implanted into a native vesselor native valve, such as a heart valve prosthesis, are with reference tothe direction of blood flow. Thus, “distal” and “distally” refer topositions in a downstream direction with respect to the direction ofblood flow and the terms “proximal” and “proximally” refer to positionsin an upstream direction with respect to the direction of blood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of embodiments hereof is in thecontext of the treatment of heart valves such as the pulmonary, aortic,mitral, or tricuspid valve, the invention may also be used in any otherbody passageways where it is deemed useful. Furthermore, there is nointention to be bound by any expressed or implied theory presented inthe preceding technical field, background, brief summary or thefollowing detailed description.

Prosthetic heart valve devices and methods described herein provide aheart valve replacement device that is sized to fit within a nativemitral valve that is screened as too small, and likely tooelliptically-shaped, to accept known mitral valve prosthesis. Inaccordance with embodiments hereof, the prosthetic heart valve devicesmay be configured for implantation within native mitral valves withannulus perimeters of between about 89 mm to about 101 mm. Theprosthetic heart valve devices described herein have the requisiteflexibility to adapt and conform to such native mitral valve anatomywhile mechanically isolating a prosthetic heart valve from an anchoringportion of the device, particularly addressing oversizing that may occurin the anterior-posterior direction of an elliptically-shaped, smallernative mitral valve. The prosthetic heart valve devices described hereineffectively absorb the distorting forces applied by the native anatomywith sufficient structural strength and integrity to withstand thedynamic conditions of the heart over time. The prosthetic heart valvedevices described herein are further configured to be delivered in aless-invasive transcatheter procedure.

FIG. 1 is a schematic sectional illustration of a heart H that depictsthe four heart chambers (right atria RA, right ventricle RV, left atriaLA, left ventricle LV) and native valve structures (tricuspid valve TV,mitral valve MV, pulmonary valve PV, aortic valve AV). FIG. 2 is aschematic sectional illustration of a left ventricle LV of a heart Hshowing anatomical structures and a native mitral valve MV. Referring toFIGS. 1 and 2 together, the heart H comprises the left atrium LA thatreceives oxygenated blood from the lungs via the pulmonary veins. Theleft atrium LA pumps the oxygenated blood through the mitral valve MVand into the left ventricle LV during ventricular diastole. The leftventricle LV contracts during systole and blood flows outwardly throughthe aortic valve AV, into the aorta and to the remainder of the body.

In a healthy heart, the valve leaflets LF of the mitral valve MV meetevenly at the free edges or “coapt” to close and prevent back flow ofblood during contraction of the left ventricle LV. Referring to FIG. 2,the valve leaflets LF attach the surrounding heart structure via a densefibrous ring of connective tissue called an annulus AN which is distinctfrom both the leaflet tissue LF as well as the adjoining muscular tissueof the heart wall. In general, the connective tissue at the annulus ANis more fibrous, tougher and stronger than leaflet tissue. The flexibleleaflet tissue of the mitral valve leaflets LF are connected topapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle LV and the interventricular septum IVS, via branchingtendons called chordae tendineae CT. In a heart H having a mitral valveMV in which the valve leaflets LF do not sufficiently coapt or meet,leakage from the left ventricle LV into the left atrium LA will occur.Several structural defects can cause the mitral valve leaflets LF toprolapse in this manner, and subsequent regurgitation to occur,including ruptured chordae tendineae CT, impairment of papillary musclesPM, e.g., due to ischemic heart disease, and enlargement of the heartand/or mitral valve annulus AN, e.g., cardiomyopathy.

FIG. 2A further illustrates the shape and relative sizes of valveleaflets LF of a mitral valve MV, and it may be seen that the overallvalve has a generally “D”-shape or kidney-like shape with a long axis LAand a short axis SA. The line of coaptation C of the valve leaflets LFis curved or C-shaped, thereby defining a relatively large anteriorleaflet AL and substantially smaller posterior leaflet PL. Both valveleaflets appear generally crescent-shaped from the superior or atrialside, with the anterior leaflet AL being substantially wider in themiddle of the valve than the posterior leaflet. As illustrated in FIG.2A, the valve leaflets LF join together at corners called theanterolateral commissure AC and posteromedial commissure PC,respectively, at the opposing ends of the line of coaptation C.

For healthy adult humans, with reference to the long axis LA and theshort axis SA shown in FIG. 2A, the long axis LA is typically within arange from about 33.6±6.0 mm to about 42.2±2.6 mm, with a standarddeviation in a range of 2.6 mm to 6.0 mm, and the short axis SA istypically within a range from about 23.8±4.0 mm to about 33.7±3.5 mm,with a standard deviation in a range of 2.2 mm to 4.0 mm. However, withadult patients having decreased mitral valve function these values canbe larger, for example, LA can be within a range from about 38.5±3.2 mmto about 52.7±3.9 mm, with a standard deviation in a range of 2.9 mm to6.0 mm, and SA can be within a range from about 26.7±2.8 mm to about37.2±0.4 mm, with a standard deviation in a range of 0.4 mm to 6.4 mm.For a patient population with diseased smaller native mitral valves tobe treated with the prosthetic heart valve devices described herein,these values may be, for example, LA within a range from about 30 mm to34 mm and SA within a range from about 24 mm to about 32 mm.

A perspective view of a heart valve prosthesis 100 in accordance with anaspect of the disclosure is shown in FIG. 3, and a sectional view of theheart valve prosthesis 100, taken along line A-A of FIG. 3, is shown inFIG. 3A. The heart valve prosthesis 100 is configured to be compressedinto a reduced-diameter delivery configuration (not shown) and to returnto an expanded, deployed configuration, as shown in FIG. 3A. Inaccordance with embodiments hereof, when in the delivery configuration,the heart valve prosthesis 100 has a low profile suitable for deliveryto and deployment within a native mitral valve via a suitable deliverycatheter that may be tracked to the deployment site of the native mitralvalve of a heart via any one of a transseptal, retrograde, ortransapical approach.

In an aspect of the disclosure, the heart valve prosthesis 100 includesa valve support 102 at least partially surrounded by an anchor element104. The valve support 102 is a hollow stent-like structure that definesa lumen 109 from an inflow end 101 of the valve support 102 to anoutflow end 103 of the valve support 102. In an aspect of thedisclosure, the valve support 102 has a first or upstream segment 102Aand a second or downstream segment 102B, with “upstream” and“downstream” referring to intended deployed positions of the respectivesegments within a native mitral valve of a heart relative to blood flowtherethrough.

The upstream segment 102A of the valve support 102 is configured tosupport a prosthetic valve component 108 therein, which will bedescribed in more detail below. The upstream segment 102A may bedescribed as having a substantially cylindrical shape with a first orupstream end 301 of the upstream segment 102A defining the inflow end101 of the valve support 102. A second or downstream end 311 of theupstream segment 102A of the valve support 102 is coextensive with afirst or upstream end 311 of the downstream segment 102B of the valvesupport 102, and a second or downstream end 303 of the downstreamsegment 102B defines the outflow end 103 of the valve support 102.

In an aspect of the disclosure, the first end 301 of the upstreamsegment 102A that defines the inflow end 101 of the valve support 102has an outer diameter D1, and the second end 303 of the downstreamsegment 102B that defines the outflow end 103 of the valve support 102has an outer diameter D2 that is greater than the outer diameter D1. Invarious aspects of the disclosure, the second end 311 of the upstreamsegment 102A and the coextensive first end 311 of the downstream segment102B have an outer diameter D3 that may be equal to or less than theouter diameter D1.

In an embodiment of a valve support 102 in which an outer diameter D1and an outer diameter D3 are equal to each other, the outer diameter D1of the upstream segment 102A may be described as being constant alongthe entire length of the upstream segment 102A from the first end 301 tothe second end 311 thereof. In such an embodiment, the outer diameter D3of the coextensive first end 311 of the downstream segment 102B is alsoequal to the outer diameter D1, such that the downstream segment 102B isflared outwardly from the outer diameter D1 at its first end 311 to theouter diameter D2 at its second end 303, with the outer diameter D2being greater than the outer diameter D1 as stated above. In an aspectof the disclosure, an upstream segment 102A having a constant outerdiameter D1 along its entire length may be described to have the form ofa hollow, substantially cylindrical shape, and a downstream segment 102Bthat flares radially, outwardly from a first end 311 having the outerdiameter D1 to a second end having the outer diameter D2 may bedescribed to have the form of a hollow, substantially frustoconicalshape. In another aspect, an upstream segment 102A having a constantouter diameter D1 along its entire length may be described to have theform of a hollow, substantially cylindrical shape, and a downstreamsegment 102B that flares radially, outwardly from a first end 311 havingthe outer diameter D1 to a second end having the outer diameter D2 maybe described to have the form of a hollow, substantially trumpet shaped.

In an embodiment of a valve support 102 in which an outer diameter D3 isless than an outer diameter D1, an upstream segment 102A graduallytapers along its length from its first end 301 having the outer diameterD1 to its second end 311 having the outer diameter D3. In an aspect ofthe disclosure, a valve support 102 having a tapered inflow profile mayimprove hemodynamics as the tapered inflow profile may promotetransvalvular blood flow and reduce the possibility of paravalvularleakage. In the aforementioned embodiment, the coextensive first end 311of the downstream segment 102B also has the outer diameter D3 that isless than the outer diameter D1, such that the downstream segment 102Bis flared radially, outwardly from the outer diameter D3 at its firstend 311 to the outer diameter D2 at its second end 303, with the outerdiameter D2 being greater than the each of the outer diameters D1 andD3.

In an aspect of the disclosure, an anchor element 104 of a heart valveprosthesis 100 is configured to mechanically isolate an upstream segment102A of a valve support 102 from the anchor element 104 when the heartvalve prosthesis 100 is deployed within a smaller, substantiallyelliptically shaped native mitral valve annulus. In an aspect of thedisclosure, the anchor element 104 is a hollow, stent-like structurethat includes a tissue fixation ring 112 and a plurality of connectors106. The tissue fixation ring 112 is a substantiallycylindrically-shaped structure that is configured to engage heart tissueat or below an annulus of a native heart valve, such as an annulus of anative mitral valve. The tissue fixation ring 112 may be configured toengage subannular tissue, such as inward-facing surfaces of the valveleaflets, as shown in FIG. 4A. The tissue fixation ring 112 functions asan anchor for the heart valve prosthesis 100 to secure its deployedposition within a native annulus. In an aspect of the disclosure, thetissue fixation ring 112 includes one or more cleats or prongs 114 thatextend outward from an exterior side of the tissue fixation ring 113 toengage heart tissue. In another aspect of the disclosure, a tissuefixation ring 113 may employ barbs, spikes, or other tissue fixationmechanisms for engaging heat tissue.

In an aspect of the disclosure, the tissue fixation ring 112 is radiallyspaced from the upstream segment 102A of the valve support 102 adistance S in an undeployed state, as shown in FIGS. 3 and 3A, and is atleast partially deformable into a non-circular shape to adapt to a shapeof an implantation site in a deployed state, such as deforming into asubstantially elliptical shape when deployed within a smaller nativemitral valve annulus. In an aspect of the disclosure, a tissue fixationring 112 and an upstream segment 102A of a valve support 102 are sizedrelative to each other to provide a distance S therebetween so as to beconfigured to prevent contact therebetween, when the heart valveprosthesis is deployed, and to thereby mechanically isolate the upstreamsegment 102A of the valve support 102 from the anchor element 104.

With reference to FIGS. 3, 3A and 4, the plurality of connectors 106 areangled radially inward from a downstream end 105 of the tissue fixationring 112 to attach to the outflow end 103 of the valve support 102. Inan aspect of the disclosure, an outflow end 103 of the valve support 102may be attached to downstream ends 115 of the plurality of connectors106 by a plurality of rivets 120. In other aspects of the disclosure,the valve support 102 and the plurality of connectors 106 of thefixation ring 112 may be coupled to each other by any of a variety ofmethods known in the art that, by way of example and not limitation, mayinclude suturing, soldering, welding, staples, or other fasteners,mechanical interlocking, snap fit, friction or interference fit, or anycombination thereof.

Each of the connectors 106 of the fixation ring 112 may be described ashaving an inwardly curved, substantially V-shape with downstream ends115 of the plurality of connectors 106 being respective vertices of theV-shape. In an aspect of the disclosure, the plurality of connectors 106may be formed by inwardly curving or bending downstream portions, ordownstream halves, of a last row of cells of the stent-like structure ofthe anchor element 104. In an aspect of the disclosure, the plurality ofconnectors 106 may extend radially inwardly and downwardly fromrespective upstream ends, which are coextensive with the downstream end105 of the tissue fixation ring, to the respective downstream ends 115thereof and are so configured to permit upward flexion of the pluralityof connectors 106, after implantation, to accommodate any radialexpansion of the tissue fixation ring 112 that may occur afterdeployment due to an increase in size of the native annulus, which mayoccur, for example, due to tissue remodeling after valve replacement,natural growth until adulthood, and/or potential disease progression.

FIG. 4 depicts a frame 430 of a heart valve prosthesis 100 in accordancewith an embodiment hereof, the frame 430 including a valve support 102and an anchor element 104. In the embodiment of FIG. 4, the valvesupport 102 of the frame 430 is formed of a stent-like structure havinghoneycomb-shaped cells and the anchor element 104 of the frame 430 isformed of a stent-like structure having closed diamond-shaped cells. Inanother embodiment shown in FIG. 5, each of a valve support 502 and ananchor element 104 of a frame 530 is formed of a stent-like structurehaving closed diamond-shaped cells.

In an aspect of the disclosure with reference to FIG. 4, an outerdiameter OD1 of an outflow end 432 of the frame 430 is a measurementthat spans a distance between outer sides of downstream ends 115A, 115Bof respective connectors 106 on opposing sides of the anchor element104. In another aspect of the disclosure with reference to FIG. 4, anouter diameter OD2 of an upstream end 107 of the anchor element 104 is ameasurement that spans a distance between outer sides of the upstreamend 107 on opposing sides of the anchor element 104, and is the broadestpoint of the anchor element 104. In accordance with an embodimenthereof, a heart valve prosthesis 100 with a frame 430 having an outerdiameter OD1 of about 30+/−0.5 mm and an outer diameter OD2 of about36+/−0.5 mm is sized for implantation within a patient having a smallernative mitral valve annulus.

In addition, with reference to FIGS. 4, 4A and 4B, a frame 430 for usein compact transcatheter heart valve prostheses in accordance withembodiments hereof has a shorter overall height H1 and a reduced coneheight H2 than conventional heart valve prostheses, which reducesprotrusion of the compact transcatheter heart valve prostheses below avalve plane of the native mitral valve into the left ventricle. Inaccordance with an embodiment hereof, a heart valve prosthesis 100 witha frame 430 having a shorter overall height H1 of about 16.2 mm+/−0.5 mmand a reduced cone height H2 of about 5.4 mm+/−0.5 mm is sized forimplantation within a patient having a smaller native mitral valveannulus to thereby reduce or prevent left ventricular outflow track(LVOT) obstruction. In an aspect of the disclosure despite this lowerprofile, the compact transcatheter heart valve prostheses perform withequivalent, or, in some cases, improved hemodynamic performance thantheir larger and taller counterparts. To demonstrate the benefit of theshorted overall height H1 and the reduced cone height H2, as well asother features, FIG. 4A depicts a side view of the frame 430 of FIG. 4in a deployed state within an annulus AN of a native mitral valve MV inaccordance with an aspect of the disclosure, and FIG. 4B depicts asectional view of a portion of the frame 430 of FIG. 4A in the deployedstate in accordance with an aspect of the disclosure. FIG. 4A only showsa frame 430 deployed within the mitral valve MV for ease ofillustration, and one of ordinary skill in the art would readilyrecognize how the illustration applies to a deployed state of a compactheart valve prosthesis 100 as shown and described with reference toFIGS. 3 and 3A-3D.

A cone height H2 of the frame 430 refers to a measurement between thedownstream end 105 of the tissue fixation ring 112 and the outflow end432 of the frame 430. The cone height H2 encompasses the plurality ofconnectors 106 of the anchor element 104. In an aspect of thedisclosure, a cone height H2 is relatively short and a remainder of theframe 430 sits at or near a valve plane of the annulus AN, with theentirety of a deployed compact heart valve prosthesis 100 being shiftedupwardly toward the left atrium LA, to thereby reduce or prevent leftventricular outflow track (LVOT) obstruction. In an aspect of thedisclosure, the reduced cone height H2 of the frame 430 also minimizescontact and/or interaction with chordae tendineae and the papillarymuscles, and provides advantages in patients with small left ventricles,who heretofore may have been screened out from receiving a mitral valveprosthesis because their annuli are too small or because there would betoo much LVOT obstruction.

As previously described above and with reference to FIGS. 4 and 4B, inan aspect of the disclosure, a tissue fixation ring 112 of a frame 430is radially spaced from an upstream segment 102A of a valve support 102a distance S in an undeployed state, and is at least partiallydeformable into a non-circular shape to adapt to a shape of the nativemitral valve annulus in a deployed state. Although once deformed thedistance S is reduced when the frame 430 is in the deployed state withina native mitral valve annulus, the tissue fixation ring 112 does notmake contact with the upstream segment 102A of the valve support 102, asshown in FIG. 4B, and thereby mechanical isolation between the upstreamsegment 102A of the valve support 102 from the anchor element 104 ismaintained when the compact heart valve prosthesis 100 is implanted invivo.

A heart valve prosthesis 100 in accordance with aspects of thedisclosure, and with continued reference to FIGS. 3 and 3A, includes abrim or rim element 110 that extends outwardly from the upstream end 107of the anchor element 104. The brim element 110 includes overlapping,180 degree out of phase sinusoidal wire forms that are attached andhinged to the anchor element 104 by a suitable biocompatible low-profilefabric 119 used in bioprosthetic implants namely endovascular grafts,heart valves or left atrial appendage devices to promotebio-integration, such as woven polyethylene terephthalate (PET) fabric.The brim element 110 may act as an atrial retainer, if present, and toserve such a function the brim element 110 may be configured to engagetissue above the native annulus AN, such as a supra-annular surface orsome other tissue in the left atrium, to thereby inhibit downstreammigration of a prosthetic heart valve 100, for e.g., during atrialsystole.

A heart valve prosthesis 100 in accordance with aspects of thedisclosure includes a prosthetic valve component 108, as previouslynoted above. FIG. 3B depicts a perspective view of a valve support 102with a prosthetic valve component 108 secured therein, the valve support102 being shown in FIG. 3B removed from the remainder of the heart valveprosthesis 100 shown in FIG. 3 for ease of illustration. FIG. 3C depictsan atrial view of the heart valve prosthesis 100 shown in FIG. 3, andFIG. 3D depicts a ventricular view of the heart valve prosthesis 100shown in FIG. 3. The prosthetic valve component 108 includes valveleaflets 117, for e.g., three valve leaflets 117, that are disposed tocoapt within the narrow upstream segment 102A of the valve support 102with the commissures 117A, 117B, 117C of the valve leaflets 117 beingsecured within the wider downstream segment 102B of the valve support102, such that the valve leaflets 117 open into the wider downstreamsegment 102B of the valve support 102 during diastole. In an aspect ofthe disclosure, the leaflet commissures 117A, 117B, 117C being arrangedwithin the wider downstream segment 102B provides the prosthetic valvecomponent 108 with a larger effective orifice area (EOA) by allowing thevalve leaflets 117 to open more without interacting with the valvesupport 102. In an aspect of the disclosure, in an open state duringdiastole, the prosthetic valve component 108 may have an effectiveorifice area greater than about 1.6 cm².

The valve leaflets 117 may be formed of various flexible materialsincluding, but not limited to natural pericardial material such astissue from bovine, equine or porcine origins, or synthetic materialssuch as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolyticcarbon, or other biocompatible materials. With certain prostheticleaflet materials, it may be desirable to coat one or both sides of thereplacement valve leaflet with a material that will prevent or minimizeovergrowth. It is further desirable that the prosthetic leaflet materialis durable and not subject to stretching, deforming, or fatigue.

In an aspect of the disclosure, FIG. 5 depicts a prosthetic valvecomponent 108 secured within a valve support 502 of a frame 530. Thevalve component 108 includes valve leaflets 117 being disposed to coaptwithin a narrow upstream segment 502A of the valve support 502 and thecommissures 117A, 117B, 117C of the valve leaflets 117 being securedwithin a wider downstream segment 502B of the valve support 502, suchthat the valve leaflets 117 open into the wider downstream segment 502Bof the valve support 502 during diastole.

In an aspect of the disclosure, a valve support 102 and a tissuefixation ring 112 may be fully lined by a low-profile fabric 119designed to provide sealing, such as that used in bioprosthetic implantsnamely endovascular grafts, heart valves or left atrial appendagedevices to promote bio-integration, such as woven polyethyleneterephthalate (PET) fabric. In an aspect of the disclosure, a woventextile may be employed that will act as a platform for subsequenttissue ingrowth. In an aspect of the disclosure, a low-profile fabric119 for attaching to the valve support 102 and the tissue fixation ring104 may be two separate pieces or types of fabric in order to mitigateleaks and reduce manufacturing time.

Any of a frame, valve support, tissue fixation ring, plurality ofconnectors, etc. described herein as an element of a heart valveprothesis 100 may be made from any number of suitable biocompatiblematerials, e.g., stainless steel, nickel titanium alloys such asNitinol™, cobalt chromium alloys such as MP35N, other alloys such asELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone,polytetrafluoroethylene (PTFE), or any number of other materials orcombination of materials. A suitable biocompatible material would beselected to provide a heart valve prothesis 100 that is configured to becompressed into a reduced-diameter delivery configuration fortranscatheter delivery to a native valve, whereby release from adelivery catheter returns the prosthesis to an expanded, deployedconfiguration.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

What is claimed is:
 1. A heart valve prosthesis, comprising: a valvesupport having an upstream segment and a downstream segment relative toblood flow through a native heart valve of a human heart, the upstreamsegment configured to support a prosthetic valve component therein anddefining an inflow end of the valve support having a first outerdiameter, and the downstream segment defining an outflow end of thevalve support having a second outer diameter that is greater than thefirst outer diameter; and an anchor element that surrounds the valvesupport, the anchor element having a plurality of connectors forming adownstream portion thereof that are angled inward toward the valvesupport and are attached to the outflow end of the valve support, andthe anchor element being spaced from the upstream segment of the valvesupport to mechanically isolate the upstream segment of the valvesupport from the anchor element.
 2. The heart valve prosthesis of claim1, wherein the first outer diameter of the upstream segment is constantfrom a first end of the upstream segment, which defines the inflow endof the valve support, to a second end of the upstream segment.
 3. Theheart valve prosthesis of claim 2, wherein the second end of theupstream segment is adjacent a first end of the downstream segment, suchthat the first end of the downstream segment has the first outerdiameter and a second end of the downstream segment, which defines theoutflow end of the valve support, has the second outer diameter.
 4. Theheart valve prosthesis of claim 2, wherein the downstream segment isflared outwardly from a first end to a second end thereof, with thefirst end of the downstream segment having the first outer diameter andthe second end of the downstream segment, which defines the outflow endof the valve support, having the second outer diameter.
 5. The heartvalve prosthesis of claim 1, wherein the upstream segment tapers from afirst end of the upstream segment, which defines the inflow end of thevalve support, having the first outer diameter to a second end of theupstream segment having a third outer diameter that is smaller than thefirst and second outer diameters.
 6. The heart valve prosthesis of claim5, wherein the second end of the upstream segment is adjacent a firstend of the downstream segment, such that the first end of the downstreamsegment has the third outer diameter, the downstream segment beingflared outwardly from the first end to a second end thereof, with thesecond end of the downstream segment, which defines the outflow end ofthe valve support, having the second outer diameter.
 7. The heart valveprosthesis of claim 1, wherein the anchor element includes a tissuefixation ring that forms an upstream portion thereof that is configuredto engage heart tissue at or below a native annulus of the native heartvalve.
 8. The heart valve prosthesis of claim 7, wherein the tissuefixation ring is radially spaced from the upstream segment of the valvesupport a distance in the undeployed state and is at least partiallydeformable into a non-circular shape to adapt to a shape of animplantation site in a deployed state, without making contact with theupstream segment of the valve support, to mechanically isolate theupstream segment of the valve support from the anchor element.
 9. Theheart valve prosthesis of claim 7, wherein the plurality of connectorsare angled inward from the tissue fixation ring.
 10. The heart valveprosthesis of claim 9, wherein the plurality of connectors areconfigured to flex upward, after implantation, to accommodate any radialexpansion of the tissue fixation ring due to an increase in size of thenative annulus with patient growth.
 11. The heart valve prosthesis ofclaim 7, wherein the tissue fixation ring includes one or more cleatsthat extend outward therefrom to engage the heart tissue.
 12. The heartvalve prosthesis of claim 1, further comprising a prosthetic valvecomponent disposed within the upstream segment of the valve support suchthat valve leaflets of the prosthetic valve component open into thedownstream segment of the valve support during diastole.
 13. The heartvalve prosthesis of claim 12, wherein in an open state during diastolethe prosthetic valve component has an effective orifice area greaterthan about 1.6 cm².
 14. The heart valve prosthesis of claim 1, whereinthe outflow end of the valve support is attached to the plurality ofconnectors by a plurality of rivets.
 15. The heart valve prosthesis ofclaim 1, wherein each of the plurality of connectors has an inwardlycurved substantially V-shape.
 16. The heart valve prosthesis of claim 1,wherein the valve support and the anchor element comprise a frame of theheart valve prosthesis.
 17. The heart valve prosthesis of claim 16,wherein the valve support of the frame is formed of a stent-likestructure having honeycomb-shaped cells and the anchor element is formedof a stent-like structure having closed diamond-shaped cells.
 18. Theheart valve prosthesis of claim 16, wherein each of the valve supportand the anchor element of the frame is formed of a stent-like structurehaving closed diamond-shaped cells.
 19. The heart valve prosthesis ofclaim 16, wherein the frame has a first outer diameter at an outflow endof the frame that is about 30 mm and has a second outer diameter at anupstream end of the anchor element that is about 36 mm, whereby theheart valve prosthesis is sized for implantation within a patient havinga smaller native mitral valve annulus.